Digital Interventions and Their Unexpected Outcomes – Time for Digitalovigilance?

Lopez-Campos, Guillermo; Gabarron, Elia; Martin-Sanchez, Fernando; Merolli, Mark; Petersen, Carolyn; Denecke, Kerstin (2024). Digital Interventions and Their Unexpected Outcomes – Time for Digitalovigilance? In: Bichel-Findlay, Jen; Otero, Paula; Scott, Philip; Huesing, Elaine (eds.) MEDINFO 2023 — The Future Is Accessible. Studies in Health Technology and Informatics: Vol. 310 (pp. 479-483). IOS Press 10.3233/SHTI231011

Preview

Text SHTI-310-SHTI231011.pdf - Published Version Available under License Creative Commons: Attribution-Noncommercial (CC-BY-NC). Download (221kB) | Preview

The application of digital interventions in healthcare beyond research has been translated in the development of software as a medical device. Along with corresponding regulations for medical devices, there is a need for assessing adverse events to conduct post-market surveillance and to appropriately label digital health interventions to ensure proper use and patient safety. To date unexpected consequences of digital health interventions are neglected or ignored, or at least remain undescribed in literature. This paper is intended to raise awareness across the research community about these upcoming challenges. We recommend that - together with developing a new research field of digitalovigilance - a systematic assessment and monitoring of adverse events and unexpected interactions be included in clinical trials, along with the reporting of such events and the conduct of meta-analyses on critical aspects.

Item Type:	Book Section (Book Chapter)
Division/Institute:	School of Engineering and Computer Science > Institute for Patient-centered Digital Health School of Engineering and Computer Science > Institute for Patient-centered Digital Health > AI for Health School of Engineering and Computer Science
Name:	Lopez-Campos, Guillermo; Gabarron, Elia; Martin-Sanchez, Fernando; Merolli, Mark; Petersen, Carolyn; Denecke, Kerstin0000-0001-6691-396X; Bichel-Findlay, Jen; Otero, Paula; Scott, Philip and Huesing, Elaine
Subjects:	Q Science > Q Science (General) R Medicine > R Medicine (General)
ISBN:	9781643684567
Series:	Studies in Health Technology and Informatics
Publisher:	IOS Press
Language:	English
Submitter:	Kerstin Denecke
Date Deposited:	14 Feb 2024 09:01
Last Modified:	14 Feb 2024 09:01
Publisher DOI:	10.3233/SHTI231011
Uncontrolled Keywords:	Digital health intervention mHealth Adverse events Medical device Digital technology Internet-based interventions
ARBOR DOI:	10.24451/arbor.21231
URI:	https://arbor.bfh.ch/id/eprint/21231